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Patent ► Subscribeprotects COLCRYS and is included in one NDA. There has been one Paragraph IV challenge on Colcrys.

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Title:

Methods for concomitant administration of colchicine and a second active agent

Abstract:

Methods for concomitant administration of colchicine together with one or more second active agents, e.g., ketoconazole and ritonavir, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for concomitant administration of colchicine together with second active agents are also provided.

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For Orange Book-listed
patents (shown in the main table above) generic applications
must certify that the listed patents are expired, invalid, or
will not be infringed by generic entry.

The non-Orange Book patents listed
below do not require formal certifications, so they do not
automatically impede generic entry. Instead, they represent
potential opportunities for branded firms to block generic
entry through patent infringment challenges.

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